Abbvie has announced secondary endpoint data from a Phase II trial investigating Rinvoq (upadacitinib) in adults with moderately to severely active systemic lupus erythematosus (SLE). The study evaluated Rinvoq as a monotherapy and in combination with elsubrutinib.

In the announcement, AbbVie noted that Rinvoq will move to a Phase III trial. However, the company is dropping the combination treatment due to no additional efficacy contribution.

Rinvoq is a selective and reversible JAK inhibitor that is being investigated in several immune-mediated inflammatory diseases. It is approved for treatment in multiple indications, such as rheumatoid arthritis, ulcerative colitis, and Crohn’s disease.

Secondary endpoint data

Abbvie announced that the trial met its primary endpoint in March 2023. The primary outcome measured SLE Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24 compared to placebo.

The company released secondary endpoint data at the European Congress of Rheumatology, EULAR 2023, which is happening from 31 May – 3 June.

Key secondary endpoints were achieved at week 48 in both treatment groups. One of the outcomes investigated time to first lupus flare measured by the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI). 30mg dose of Rinvoq and a high dose of ABBV-599 showed a greater treatment effect compared to the placebo.

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The 30mg dose of Rinvoq and a high dose of ABBV-599 also achieved other outcomes measuring disease activity and treatment response compared to the placebo. No new safety signals were reported beyond the already established safety profile for Rinvoq.

The Phase II trial (NCT03978520) enrolled 341 patients who underwent standard lupus therapy. Subjects were randomised to receive a once-daily high or low dose of ABBV-599, 60mg dose of elsubrutinib, 30mg dose Rinvoq or placebo.

Upcoming Phase III trial

Alongside the announcement of meeting the primary endpoint, Abbvie teased about moving Rinvoq to a Phase III trial. This was reiterated in today’s announcement on secondary endpoints.

According to the registry, the Phase III trial (NCT05843643) will be initiated on 30 June and will recruit 1000 patients. The primary endpoint will measure the percentage of participants achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response.

SLE prevalence

SLE, the most common type of lupus, is an autoimmune disease where the immune system attacks its own tissues. GlobalData epidemiologists forecast that there are more than 240,000 diagnosed prevalent cases of SLE in the US in 2023. The number of prevalent cases will increase to 260,000 in 2031 at an annual growth rate of 1.00%.

The epidemiologists also forecast that almost 90% of new cases will be diagnosed in women and around 70% of cases will be moderate or severe in complication. They also noted that SLE cases are still diagnosed at a later stage in minority racial groups compared to non-minority groups.